FDA rejects MDMA therapy for PTSD amid safety concerns

The Food and Drug Administration (FDA) rejected Lykos Therapeutics’ request to approve an MDMA-based drug for treating post-traumatic stress disorder (PTSD).

The FDA cited concerns about the safety and reliability of the clinical data submitted, noting a lack of sufficient evidence of safety and effectiveness. 

The agency has requested Lykos for additional phase 3 trials to evaluate MDMA’s safety and effectiveness as a treatment.

The drugmaker had proposed using MDMA (popularly known as ecstasy) alongside talk therapy to treat PTSD, marking it the first Schedule 1 psychedelic the FDA reviewed for medical use.

The decision is a setback for companies like Compass Pathways and Tactogen advocating the legalization of psychedelics for mental health treatments. Currently, around 50 MDMA trials are in progress in the US, according to ClinicalTrials.gov.

PTSD affects approximately 13 million Americans, including several veterans.

While MDMA is popular recreationally for its euphoric effects, it carries serious risks like organ failure and brain swelling. It remains illegal outside specific, approved medical settings.